Engineer Manufacturing
Resume:
WHITNEY S. HAMNETT
** *** ****** ****, *******, MA 01742
***.****@*****.***
SUMMARY
An Engineering professional with expertise in medical device quality, research and development, new product introduction, and manufacturing process improvement. Kaizen and lean manufacturing. Strengths include adaptability to a broad range of products, technologies, and industries; and desire and ability to take on high stakes challenges that result in immediate and long range bottom line impact.
PROFESSIONAL EXPERIENCE
INSULET CORPORATION, Bedford, Ma. September 2011
Contract Manufacturer: Flextronics Technology Company Limited Block C7-C11, 2nd Industrial Zone Xixiang, Shenzhen, Guangdong PRC 518126 China
Senior Manufacturing Engineer
Engineering support for manufacturing of OmniPod Insulin delivery systems. The OmniPod Insulin Management System is used in the management of insulin therapy and blood glucose monitoring by patients with diabetes mellitus. Process Characterization, Qualification and Validation (IQ, OQ, PQ). DOE, SPC, D/PFMEA, cGMP, QSR (ISO13485, ISO10993). Failure Investigations, CAPA’s and NCR’s.
MEDTRONIC CARDIOVASCULAR, INC., Danvers, Ma. September 2004-July 2011
Senior Manufacturing Engineer, Medtronic Outsourcing Manufacturing Group
Coordinating the outsourcing of the PTCA Guide Wire product lines from Medtronic to OEM Vendor in the Dominican Republic. Responsible for on-site coverage and equipment and process validations (IQ,OQ,PQ). Coordinate operator training and certification, Systems integration and offload efforts at vendor site. Project complete
Q4’ 2011.
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MEDTRONIC CARDIOVASCULAR, INC., Danvers, Ma. September 2004-July2011
Senior Manufacturing Engineer
Engineering support for manufacturing of Coronary, Endovascular, and Peripheral PTCA guide wires for interventional procedures utilizing balloon angioplasty catheters, guide catheters, guide wires, and diagnostic catheters and accessories. Developed and implemented process and product improvements resulting in $800K cost reduction/avoidance in reduced scrap and significantly increased production yields (Cougar Guide Wires). Implemented a solvent recovery system to distill and reuse Silicone carrier solvents for a $150K per year cost savings. Met and exceeded departmental goals and objectives. Process Characterization, Qualification and Validation (IQ, OQ, PQ). Continuous process improvement and cost analysis. DOE, SPC, D/PFMEA, cGMP, QSR (ISO13485). Six Sigma training and Lean Manufacturing training (Green Belt) and implementation experience. Team leader on multiple projects including: Failure Investigations, CAPA’s and NCMR’s. Timely resolution of production floor issues. Development and documentation of inter-disciplinary teams to resolve high profile production issues.
SMITH & NEPHEW, INC., Endoscopy Division, Andover, Ma. 1998-2004
Manufacturing Engineer
Engineering support for manufacturing disposable medical devices. cGMP/QSR. ISO-9001. Final assembly packaging and labeling systems on SAP supported software. Form, fill and seal (PETG) packaging equipment (Tiromat/CFS), pouch packaging, ink jet and thermal ribbon printing systems, Labelvision software.
Engineering support for new products and product line extensions for disposable medical devices. Engineering support for packaging and final assembly.
Manufacturing process validations. Accelerated age studies and ship testing for all products and packaging. DOE’s, P/DFMEA’s, SPC. Process improvements contributing to significant annual cost reductions (elimination of 12 operator final assembly third shifts production) with improved process yields and significant reduction in quality related NCMR’s. Engineering ECO support for BOM’s and Routings. SAP based software. Designed and developed high-speed automated One Piece Tube manufacturing production equipment. $1MIL cost reduction in first year of implementation. Designed, developed and validated a production blade vision (Cognex) recognition system for edge form verification to reduce the possibility of mixed product. Developed mold automation equipment to replace over-molding blade processing with automated blade assembly system. Significant cost reduction and head count reduction. Developed new (and improved existing) products and processes through development of vendor relations in packaging/materials design and implementation. Developed Medical Grade Silicone (Dow Corning MDX4-4159) blade lubrication system and cure process for all disposable blade applications. Materials research and analysis for product improvement and CAPA.
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MICRION CORP. (FEI, Inc.), Peabody, Ma. 1995-1998
Engineer/Optics Department
Build, test and troubleshoot Focused Ion Beam Systems / (SIM) utilized in semiconductor manufacturing and metrology in a production environment.
Design and operation of vacuum systems (ultrahigh vacuum systems: ion pumps, cryopumps, TSPs, and gettering pumps). Leak detection, Varian certified.
OPTRON SYSTEMS, INC. Bedford, Ma. 1988-1995
Engineer/Department Manager
Design, development and operation of a thin film fabrication facility: R.F. magnetron sputtering, eBeam evaporation, microlithography, photocathode processing. New product development.
KAMAN/ELECTROMAGNETICS, Hudson, Ma. 1983-1988
Production Manager
Established and managed a research and development laboratory for DARPA sponsored experimental research of high voltage/high current electromagnetic accelerators. Original founding member of company.
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MASSACHUSETTS INSTITUTE OF TECHNOLOGY, Cambridge, Ma. 1973-1983
Engineering Aide
Francis Bitter National Magnet Laboratory. Research and development of electromagnetic accelerators.
Build, test and troubleshoot superconducting magnets used in experimental nuclear fusion reactor containment vessels.
Center for Space Research. Build, test and troubleshoot systems and experiments used in high-energy astrophysics/satellite payloads. Thermal protection systems. World wide travel for launch support.
EDUCATION/PROFESSIONAL CERTIFICATION
Chaffey College, Alta Loma, Ca. Associate Degree (1969)
University of Massachusetts/College of Art, Boston, Ma. Bachelor Degree (1973)
Worcester Polytechnic Institute, Worcester, Ma. Certification of Completion
Six Sigma Process Improvement Program, (1999)
SPC, DOE, FMEA, Process Improvement
Medtronic Cardiovascular, Danvers Ma.
Engineer Technical Certificate Program, Certificate of Completion (2006)
AAMI, Design Control-Requirements and Industry Practice
Certificate of Completion (2004)
Worcester Polytechnic Institute, Worcester, Ma. Certification of Completion
Project Management Certificate (2005)
Statistical Methods for Engineers (2005)
Statistical Process Control (2005)
United States Racquet Stringers Association
Master Racquet Technician Designation/Certification (2003-2011)
AWARDS
1984
Original Crewmember of M.I.T.’s “Monarch human powered aircraft program. Designed, built, flew and won the British Royal Aeronautical Societies “Kremer Prize for speed in a human powered aircraft.
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